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to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients
Comparing the effect of Combination therapy (Li-ESWT combined with PDE5-inhibitor) vs SIngle therapy (PDE5-inhibitor) in mild to moderate Erectile Dysfunction patients.
Parameters used for comparation are EHS score, IIEF-5 score, VEGF level and PSV
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy | Experimental | Li-ESWT + tadalafil |
|
| Single Therapy | Sham Comparator | tadalafil only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Li-ESWT | Procedure | Li-ESWT twice weekly for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Hardness Score (EHS) | Developed in 1998, the EHS is a single-item Likert scale that men can use on their own. The tool asks them to consider the question "How would you rate the hardness of your erection?" and select one of the following options: 0 Penis does not enlarge
The EHS score was taken pre and post intervention | 4 weeks |
| International Index of Erectile Function (IIEF-5) score | IIEF-5 is a tool for ED (Erectile Dysfunction)diagnosis. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25) IIEF-5 score was taken pre and post intervention | 4 weeks |
| Peak Systolic Velocity (PSV) | PSV was measured in cm/s, by using Doppler Ultrasonography. The probe is located at the penis, to be precise in the penoscrotal junction, to measure the velocity of the blood flow in the cavernous arteries. The test was done in flaccid state of the penis Measurement was taken by an experienced ultrasonographer in the radiology unit. Measurement was taken pre and post intervention | 4 weeks |
| Vascular Endothelial Growth Factor (VEGF) level in plasma | VEGF was measured in pg/ml. VEGF test were done by blood test in the laboratory using the VEGF-A ELISA Kit. Blood for tests were drawn pre and post test | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Only for male
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| Name | Affiliation | Role |
|---|---|---|
| Tjahjo Tanojo, dr | Dr. Soetomo General Hospital, Andrology Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| dr. Soetomo General Hospital | Surabaya | East Java | 60286 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol Chart | Dec 1, 2019 | Aug 31, 2021 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Ethical Clearance | Dec 9, 2019 | Aug 31, 2021 | Prot_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocols and Statistical Analysis Plan | Dec 1, 2019 | Sep 9, 2021 | Prot_SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistics Results | Jun 14, 2020 | Aug 31, 2021 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2019 | Aug 31, 2021 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| Tadalafil 2.5Mg Tab | Drug | tadalafil 2.5mg once daily |
|
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |